An interventional study of Surgical Group and Physical Therapy Group in Carpal Tunnel Syndrome, sponsored by Universidad Rey Juan Carlos. Completed at 2 sites in Spain. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-05-12.
Sponsored by Universidad Rey Juan Carlos · Not applicable, Interventional, and Treatment
This randomized clinical trial will investigate changes in pain intensity and nociceptive gain processing after the application of either physical therapy or surgery in women with carpal tunnel syndrome (CTS). The purpose of this study will be to determine changes in pain intensity, widespread pressure pain sensitivity and segmental thermal changes after the application of a physical therapy program based on desensitization maneuvers of the central nervous system or endoscopic surgery in women with CTS at medium and long-term follow-up periods. We hypothesize that the physical therapy intervention targeted to desensitization of the central nervous system is more effective than surgical intervention for modulating altered nociceptive gain processing in women with CTS.
There is increasing evidence suggesting that carpal tunnel syndrome (CTS) represents a complex pain syndrome including both peripheral and central sensitization mechanisms. In fact, patients with unilateral CTS exhibit bilateral widespread pressure hyperalgesia and bilateral pain hypersensitivity suggesting the presence of altered nociceptive gain processing. In addition, these sensitization processes seem to be independent of electro-diagnostic findings. Previous studies support the use of physical therapy and surgical interventions for the management of pain and disability in these patients. However, there is no evidence related to changes in nociceptive gain process after the application of any therapeutic intervention. Preliminary evidence suggests that manual therapies can modulate sensitization mechanisms. Therefore, our objective is to conduct a randomized clinical trial to determine if manual therapies including desensitization maneuvers of the central nervous system are effective to decrease widespread pressure pain and thermal pain hypersensitivity in women with CTS.
589 studies on the registry are indexed under Carpal Tunnel Syndrome; 139 are open to participants now.
This study's enrollment of 100 is above the median of 60 across 445 interventional studies indexed under Carpal Tunnel Syndrome.
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Exclusion Criteria:
The physical therapy group will receive 3 treatment sessions of manual therapy including desensitization maneuvers of the central nervous system of 30 minutes of duration, once per week.
Other: Physical Therapy Group
The surgical group will receive a surgical procedure consisting of the decompression and release of the median nerve at the carpal tunnel performed by an experienced surgeon according to standardized protocols.
Other: Surgical Group
The surgical group will receive a surgical procedure consisting of the decompression and release of the median nerve at the carpal tunnel performed by an experienced surgeon according to standardized protocols.
The physical therapy group will receive 3 treatment sessions of manual therapy including desensitization maneuvers of the central nervous system of 30 minutes of duration, once per week.
Changes in widespread pressure pain thresholds between baseline and follow-up periods
Pressure pain thresholds over the median, ulnar and radial nerves, and over the cervical spine, the second metacarpal, and tibialis anterior muscles will be bilaterally assessed.
Time frame: Baseline and 3, 6, 9 and 12 months after the intervention.
Changes in heat and cold pain thresholds between baseline and follow-up periods
Heat and cold pain thresholds over the carpal tunnel and the thenar eminence will be bilaterally assessed.
Time frame: Baseline and 3, 6, 9 and 12 months after the intervention
Changes in pain intensity between baseline and follow-ups periods
An 11-point Numerical Pain Rating Scale (NPRS, 0: no pain - 10: maximum pain) will be used to assess the patients' current level of hand pain and the worst and lowest level of pain experienced in the preceding week. The mean value of the 3 scores will be used in the analysis at each follow-up period.
Time frame: Baseline and 3, 6, 9 and 12 months after the intervention
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Universidad Rey Juan Carlos